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Brilliance Elite

by Changzhou Sifary Medical Technology Co., Ltd. 8 variants

Ref 5088197Model ibT5035E, ibT5040E, ibT5045E, ibT5050E

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697259778IB016LU Basic UDI-DI 06941877834470UDI-DIDate29 Jul 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Surgical Binocular Loupes
Model / reference
ibT5035E, ibT5040E, ibT5045E, ibT5050E, 5088197
Primary DI / UDI-DI
06941877834470
Basic UDI-DI
697259778IB016LU
EMDN code
L0316 Helmets and binocular glasses for surgeons
Device class
Class I
EU registration type
Standard device
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CN-MF-000010405
Authorised representative
Caretechion GmbH DE-AR-000005946

Other devices from Changzhou Sifary Medical Technology Co., Ltd.

See all devices from Changzhou Sifary Medical Technology Co., Ltd. →

Properties

Other properties (14)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No